Placebo-controlled, double-blind, randomized pilot study of imiquimod 5% cream applied once per week for 6 months for the treatment of actinic keratoses.
BACKGROUND
Imiquimod 5% cream applied twice weekly for 16 weeks is effective for treating actinic keratoses but may be limited by local side effects.


OBJECTIVE
We sought to explore the efficacy and safety of a once weekly for 24 weeks dosing regimen using a left versus right side of head design.


RESULTS
Twenty patients were enrolled; 15 completed and 5 discontinued for reasons unrelated to adverse events. At the posttreatment visit (week 28), 7 (46.7%) of 15 patients had marked improvement or better on the imiquimod side versus one (6.7%) of 15 on the placebo side. The average investigator assessment scale score change was +2.20 for imiquimod compared with -0.27 for placebo (P = .0002, Wilcoxon signed rank test). Skin reactions were minimal or nonexistent in most patients.


CONCLUSIONS
Limitations of the study include a small sample size and a lack of objective measure of local side effects.


CONCLUSIONS
Imiquimod 5% cream applied once weekly for 24 weeks was convenient for patients and resulted in improvement of actinic keratoses with minimal side effects.
Zeichner
Joshua A
JA
Mount Sinai Medical Center, New York, New York, USA.
Stern
Dana W K
DW
Uliasz
Annemarie
A
Itenberg
Sarit
S
Lebwohl
Mark
M
D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000368:Aged; D000634:Aminoquinolines / Q000008:administration & dosage*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D000077271:Imiquimod; D055623:Keratosis, Actinic / Q000188:drug therapy*; D008297:Male; D004364:Pharmaceutical Preparations; D010865:Pilot Projects; D013997:Time Factors
D000276:Adjuvants, Immunologic; D000634:Aminoquinolines; D004364:Pharmaceutical Preparations; D000077271:Imiquimod